Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Обзор

The investigators will conduct a 13,000-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries

Вмешательства

• Другое Anesthetic technique Propofol TIVA
  Propofol TIVA no inhaled agent
• Другое Anesthetic technique inhaled agent
  Must administer inhaled agent.

Первичные конечные точки

• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery [Срок оценки: Postoperative day 1]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery [Срок оценки: Postoperative day 1]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery [Срок оценки: Postoperative day 1]
• Incidence of definite intraoperative awareness with recall [Срок оценки: Postoperative day 30]

Вторичные конечные точки (12)

• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery [Срок оценки: postoperative day 0]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery [Срок оценки: postoperative day 0]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery [Срок оценки: postoperative day 0]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery [Срок оценки: postoperative day 2]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery [Срок оценки: postoperative day 2]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery [Срок оценки: postoperative day 2]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery [Срок оценки: postoperative day 7]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery [Срок оценки: postoperative day 7]
• Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery [Срок оценки: postoperative day 7]
• Days Alive and at Home at 30 days after major inpatient surgery [Срок оценки: postoperative day 30]
• Days Alive and at Home at 30 days after minor inpatient surgery [Срок оценки: postoperative day 30]
• Days Alive and at Home at 30 days after outpatient surgery [Срок оценки: postoperative day 30]

Критерии участия

Критерии включения

Each patient must meet all of the following criteria:

• Aged 18 years or older
• Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

Критерии исключения

Patients will not be enrolled if any of the following criteria are met:

• Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
• Pregnancy (based on patient report or positive test on the day of surgery)
• Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
• Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report
• Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
• Locally approved, written protocol mandating a particular anesthetic technique
• History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
• Planned postoperative intubation
• Current incarceration

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 20 центров

• University of Arkansas for Medical Sciences (UAMS) — Little Rock
• University of California San Francisco — San Francisco
• Stanford University — Stanford
• Yale School of Medicine — New Haven
• Massachusetts General Hospital — Boston
• Brigham & Women's — Boston
• University of Michigan — Ann Arbor
• Henry Ford Health — Detroit
• … и ещё 12 центров

Публикации

• Tellor Pennington BR, Janda AM, Colquhoun DA, Neuman MD, Kidwell KM, Spino C, Thelen-Perry S, Krambrink A, Huang S, Ignacio R, Wu Z, Swisher L, Cloyd C, Vaughn MT, Pescatore NA, Bollini ML, Mashour GA, Hassett A, Kent CD, Vlisides PE, Avidan MS, Kheterpal S; ˠTHRIVE Research Group. Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlle PMID 40953862

Идентификаторы

NCT: NCT05991453 · 202304082

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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